DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Patients who meet all of the following conditions are included.
• Patients aged ≥ 18 years and;
• Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
• Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
• Patients who have been informed of the characteristics of the study and have provided their written informed consent.
Locations
Other Locations
Spain
Hospital Universitario de Cabueñes
RECRUITING
Gijón
Hospital Universitario de Leon
RECRUITING
León
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Contact Information
Primary
IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD
inigo.lozano@fundacionepic.org
0034630901145
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987876135
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 94
Treatments
Active_comparator: Drug Coated Balloon (DCB)
Drug Coated Balloon (DCB)
Experimental: Drug Eluting Stent (DES)
Drug Eluting Stent (DES)
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC